MAUDE Adverse Event Report: GYRUS ACMI, INC. PK CUTTING FORCEPS, 5MM, 33CM; ELECTROSURGICAL HANDPIECE CUTTING FORCEPS

Model Number PK-CF0533

Device Problem Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the reported issue is unknown at this time.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported during a laparoscopic bilateral salpingectomy procedure, the device stopped coagulating after two uses.No error messages on the machine were observed when the problem occurred.No other devices connected to the subject device when the failure occurred.According to the reporter, it was unsure of how long the procedure was, but it was extended by 15 minutes while the issue was being troubleshooted.The intended procedure was completed by switching to ligasure (third party device).No harm was reported , no impact or harm to the patient, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device return evaluation and legal manufacturer's final investigation.Additionally, please see corrected data in d4 : unique identifier (udi) number was updated from (b)(4) to (b)(4) per the device history record (dhr) records.The correct udi is (b)(4) and not (b)(4).The subject device was received and evaluated.The returned device (pk-cf0533 lot number fr247039) was inspected.The complaint was not confirmed.The device was returned in non-original package.The device was received with the jaws opened, lock on.A visual inspection found no foreign material located on the jaws.The jaw symmetry was balanced, no visual damage noted.The first point of contact for the jaws was at the distal end; this was consistent with standard.The jaw aperture measurement was taken inside the first teeth of the jaw, measured at approximately.300", (standard is.300¿ +/-.100¿).The jaw mesh was not good as the gap between the teeth was not uniform at all locations.The insulation of the jaw legs was inspected and found scrapes and tears which have small areas of exposed metal.The flare was intact and had no cracks.The blade extended/retracted and cut the dental dam as designed.The lock function engaged/released as designed and the shaft was normal.The device was plugged into the "universal socket" of a test esg-400, the default setting displayed pkcoag at power level 100 effect 3 with the pk cut mode off.Testing performed, grasped a wet cotton pad soaked in saline with the jaws of the pk cutting forceps, the blue switch on the forceps was pressed and observed vapors of moisture indicating the coag function was working as energy was being provided through the distal end.Testing performed, activated the blue coag switch several times and verified vapors of moisture every time coagulation was activated.Based on the device inspection, the complaint of "coagulation stopped working" was not confirmed as the coag function was working when tested.Device history record was reviewed and showed the product met all specifications upon release.Even though the complaint could not be confirmed, the reported failure is a known phenomenon likely resulting from having the distal jaw tips come in contact with each other when attempting to coagulate.On page 3 of the device ifu (instructions for use_p9100528-001_ad), it states: "if forceps jaws come in contact with each other when the power is activated, instrument will short out and the generator display will show ¿re-grasp¿.Release the forceps jaws so they are not in contact with each other and the device will become operational." olympus will continue to monitor complaints for this device.

• Brand Name: PK CUTTING FORCEPS, 5MM, 33CM
• Type of Device: ELECTROSURGICAL HANDPIECE CUTTING FORCEPS
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16066312
• MDR Text Key: 306520898
• Report Number: 3005975494-2022-00073
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925035850
• UDI-Public: 00821925035850
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PK-CF0533
• Device Lot Number: FR247039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1